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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Controls (Assayed And Unassayed)
510(k) Number K944243
Device Name CARDIOCHEX
Applicant
Cala Diagnostics
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Applicant Contact JAMES F GODFREY
Correspondent
Cala Diagnostics
750 Farroll Rd.
Suite B
Grover Beach,  CA  93433
Correspondent Contact JAMES F GODFREY
Regulation Number862.1660
Classification Product Code
JJT  
Date Received08/31/1994
Decision Date 10/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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